According to the World Cancer Research Funds and the American Institute for Cancer Research, in 2018, there were around 18 million cases of cancer, of which around 9.5 million were in men and around 8.5 million in women, globally. Moreover, introduction of innovative products and rich pipeline of cell and gene therapy is expected to boost the market growth. For instance, around 150 gene therapies are currently in the development stage. Gene replacement accounts for around two third of gene therapy pipeline. However, around 49% of gene therapies are under preclinical and discovery stages. During 2012-18, around 351 gene therapy deals were signed. For instance Gilead’s Kite Pharma received exclusive rights to Sangamo Therapeutics’ zinc finger nuclease gene editing technology, for $3.2bn.
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According to the World Health Organization (WHO), May 2017, around 17.9 million people died due to cardiovascular disease in 2016 globally, which accounts for 31% of all worldwide deaths. According to WHO, in 2012, cancer was the second leading cause of morbidity and mortality globally, with around 14 million new cases registered in 2012 and in 2015, cancer was responsible for 8.8 million deaths, worldwide. Moreover, WHO stated that the number of new cases is expected to rise by around 70% by 2030.
Furthermore, introduction of effective guidelines is expected to propel growth of the global cell and gene therapy market over the forecast period. For instance, the U.S. Food and Drug Administration (FDA) included around 28 guidelines documents from 1998 to 2018 regarding various cell and gene therapies. However, several development challenges such as safety and efficacy issues, lengthy procedures for conducting clinical studies, stringent regulatory framework, and high costs are expected to limit the adoption of cell and gene therapy, thereby hindering the market growth.
Moreover, in November 2011, New York Blood Center, Inc. received approval from FDA for Hemacord. It is indicated for unrelated donor hematopoietic progenitor cell transplantation procedures and in patients with disorders affecting the hematopoietic system that are inherited, acquired, or results from myeloablative treatment in children. In October 2017, Kite Pharma received approval from the U.S. FDA for Yescarta (axicabtagene ciloleucel), which is used for the treatment of adults with large B-cell lymphoma. It was the first chimeric antigen receptor (CAR) T-cell therapy to receive FDA approval for large B-cell lymphoma.
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Key players in the market are focused on adopting strategies such as mergers and acquisitions to enhance their product portfolio. For instance, in June 2017, Johnson & Johnson acquired Actelion Ltd. Moreover, in October 2017, Gilead Sciences acquired Kite Pharma. Kite Pharma is involved in developing chimeric antigen receptor T-cell therapy, to recognize and attack malignant cells.
Major players operating in the global cell and gene therapy market include Amgen, Biogen, BioMarin Pharmaceuticals, Bristol-Myers Squibb Company, GlaxoSmithKline, Novartis, Pfizer, Regeneron Pharmaceuticals and Sanofi, Spark Therapeutics, Agilis Biotherapeutics, Angionetics AVROBIO, Freeline Therapeutics, Horama, MeiraGTx, Myonexus Therapeutics, Nightstar Therapeutics, Kolon TissueGene, Inc., JCR Pharmaceuticals Co., Ltd., and MEDIPOST.